510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790418Substantially Equivalent

Model 8100 Pre-Filled Intrauterine

GE Medical Systems Information Technologies, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790418 is the FDA 510(k) clearance record for MODEL 8100 PRE-FILLED INTRAUTERINE, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code KXO (Monitor, Pressure, Intrauterine). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K790418.

Clearance record

Decision date
Received
(21 days to decision)
Product code
KXO Monitor, Pressure, Intrauterine
Regulation
21 CFR 884.2700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ge Medical Systems Information Technologies 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KXO

Trailing 12 months

FDA records hold no clearances under product code KXO in the trailing twelve months.

FDA records show no clearances under product code KXO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260